Pharmaceutical Services Regulations (Northern Ireland) 1997

Statutory Rules of Northern Ireland

1997 No. 381

HEALTH AND PERSONAL SOCIAL SERVICES

Pharmaceutical Services Regulations (Northern Ireland) 1997

Made

15th August 1997

Coming into operation

6th October 1997

The Department of Health and Social Services, in exercise of the powers set out in Schedule 1 and of all other powers enabling it in that behalf, and in conjunction with the Department of Finance and Personnel and after consultation with such organisations as appeared to the Department of Health and Social Services to be representative of the pharmaceutical profession as required by Article 63(3) of the Health and Personal Social Services (Northern Ireland) Order 1972(1), hereby makes the following Regulations:

PART I GENERAL

Citation and commencement

1.  These Regulations may be cited as the Pharmaceutical Services Regulations (Northern Ireland) 1997 and shall come into operation on 6th October 1997.

Interpretation

2.—(1) In these Regulations—

“appliance” means an appliance which is included in a list for the time being approved by the Department for the purposes of Article 63 of the Order(2);

“appropriate non-proprietary name” means a non-proprietary name which is not mentioned in Schedule 10 to the Medical Regulations or, except where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied, in Schedule 11 to those Regulations;

“Board” means a Health and Social Services Board established under Article 16 of the Order for any area;

“chemist” means—

(a)

a pharmacist;

(b)

a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968(3); or

(c)

a supplier of appliances;

who is included in the pharmaceutical list under Article 63 of the Order;

“child” means a person who has not attained the age of 16 years;

“dentist” means a dental practitioner;

“Disciplinary Procedures Regulations” means the Health and Personal Social Services (Disciplinary Procedures) Regulations (Northern Ireland) 1996(4);

“doctor” means a medical practitioner;

"doctors' terms of service" means the terms of service contained in Schedule 2 to the Medical Regulations;

“drugs” includes medicines and chemical reagents;

"Drug Tariff' has the meaning given to it in regulation 9;

“joint discipline committee” has the same meaning as in the Disciplinary Procedures Regulations;

“listed drugs” means the drugs included in a list for the time being approved by the Department for the purposes of Article 63 of the Order;

“Local Dental Committee”, “Local Medical Committee” and “Local Pharmaceutical Committee” mean the respective committees of those names which are recognised by a Board in relation to its area under Article 55 of the Order(5);

“maternity medical services” has the meaning assigned to it by regulation 34 of and Schedule 5 to the Medical Regulations;

“medical list” has the meaning assigned to it by regulation 4 of the Medical Regulations;

“Medical Regulations” means the General Medical Services Regulations (Northern Ireland) 1997(6);

“non-proprietary name”, in relation to a drug, means—

(a)

where the drug is described in a monograph in the current edition (as defined in section 103(5) of the Medicines Act 1968(7)), as in force at the time of the supply of the drug, of the European Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary, the International Pharmacopoeia, the Cumulative List of Recommended International Non-proprietary Names or the Dental Practitioners' Formulary, any name, or abbreviation of such name, at the head of that monograph or, where such name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or

(b)

where the drug is not so described but has an approved name, being the name which appears in the current edition (as defined in section 103(5) of the Medicines Act 1968) of the list of names prepared and published under section 100 of that Act, as in force at the time of the supply of the drug, such approved name;

“nurse prescriber” means a nurse or health visitor of a description specified in paragraph (2);

“obstetric list” has the meaning assigned to it by regulation 30 of the Medical Regulations;

“the Order” means the Health and Personal Social Services (Northern Ireland) Order 1972;

“patient” has the same meaning as in paragraph 3 of Schedule 2 to the Medical Regulations;

“pharmaceutical discipline committee” has the same meaning as in the Disciplinary Procedures Regulations;

“pharmaceutical list” shall be construed in accordance with regulation 6;

“pharmacist” means a pharmacist, other than a supplier of appliances only, whose name is included in the pharmaceutical list under Article 63 of the Order or who is employed by a person (including a body corporate) whose name is so included;

“pharmacy” means any premises where drugs or appliances are provided by a pharmacist pursuant to arrangements made under Article 63 of the Order;

“prescription form” means a form provided by the Agency and issued by a doctor or dentist to enable a person to obtain pharmaceutical services under Article 63(1)(a) or (b) of the Order or a form provided by the Agency for the purposes of pharmaceutical services under Article 63(1)(bb) of the Order and issued by a nurse prescriber to enable a person to obtain such services;

“reagent” means a chemical reagent included in a list for the time being approved by the Department;

“relevant service” has the same meaning as in section 64(1) of the Reserve and Auxiliary Forces (Protection of Civil Interests) Act 1951(8) as extended to Northern Ireland by the Reserve and Auxiliary Forces (Protection of Civil Interests) (Northern Ireland) Order 1979(9) and includes services rendered under the Reserve Forces Act 1980(10);

“Scheduled drug” means a drug or other substance specified in Schedule 10 to the Medical Regulations or, except where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied, Schedule 11 to those Regulations;

“suspended by direction of the Tribunal” means suspended as respects the provision of pharmaceutical services by a direction of the Tribunal made pursuant to paragraph 8A(2) or 8B(1) of Schedule 11 to the Order(11) or to equivalent provisions in force in England and Wales or Scotland corresponding to those provisions;

“terms of service” means the terms of service contained or referred to—

(a)

in relation to chemists, in Parts I and II of Schedule 2;

(b)

in relation to doctors who provide pharmaceutical services, in Parts I and III of Schedule 2; and

“working day” means any week-day other than a public holiday.

(2) The specified description of nurse or health visitor mentioned in the definition of “nurse prescriber” in paragraph (1) is—

(a) a person who—

(i) is registered in Part 1 or 12 of the Register maintained by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting under section 10 of the Nurses, Midwives and Health Visitors Act 1979(12) (referred to in this paragraph as “the professional register”); and

(ii) has a district nursing qualification additionally recorded in the professional register under rule 11 of the Nurses, Midwives and Health Visitors Rules 1983(13); and

(iii) is at the time of ordering the listed drug or medicine or appliance, employed by a Board or an HSS trust as a district nurse, or employed as a nurse by a fundholding practice whose recognition as such by virtue of Article 17 of the Health and Personal Social Services (Northern Ireland) Order 1991(14) (recognition of fundholding practices of doctors) has taken effect; or

(b) a person who—

(i) is registered in Part 11 of the professional register as a health visitor; and

(ii) is, at the time of ordering the listed drug or medicine or appliance, employed by a Board or an HSS trust as a health visitor, or employed as a nurse by a fundholding practice whose recognition as such by virtue of Article 17 of the Health and Personal Social Services (Northern Ireland) Order 1991 has taken effect;

against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients.

(3) The Interpretation Act (Northern Ireland) 1954(15) shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly.

PART II PROVISION OF PHARMACEUTICAL SERVICES BY CHEMISTS

Pharmaceutical services

3.—(1) The arrangements for the provision of pharmaceutical services by chemists shall include arrangements for—

(a) the supply of contraceptive substances and appliances; and

(b) the provision of supplemental services.

(2) The arrangements referred to in paragraph (1) shall incorporate the terms of service for chemists set out in Part II of Schedule 2.

(3) In these Regulations “supplemental services” means—

(a) giving advice, in connection with the safe keeping and correct administration of drugs provided to persons resident in a home, to the person appearing to the chemist to be in charge of the home, or to the person authorised by that person to control such safe keeping and correct administration; and

(b) keeping records of visits made to those homes.

(4) In paragraph (3)—

(a) “home” means any one of—

(i) a residential home provided under Article 15 of the Order; or

(ii) a residential care home registered under Article 6 of the Registered Homes (Northern Ireland) Order 1992(16), but excluding a “small home” as defined in Article 4(5) of that Order; or

(iii) a nursing home registered under Article 19 of the Registered Homes (Northern Ireland) Order 1992;

(b) “records” in relation to a visit by a chemist to a home shall include—

(i) the name and address of the home;

(ii) the date of each visit by that chemist; and

(iii) the nature of any advice given by him in the course of or following each such visit and to whom it was given.

(5) A chemist may at any time give notice in writing to the Board that he wishes to be—

(a) included in or excluded from any arrangements for the supply of contraceptive substances and appliances; or

(b) included in or excluded from any arrangements for the provision of “supplemental services”.

Additional professional services

4.—(1) A chemist may, in addition, undertake to provide additional professional services.

(2) In these Regulations, “additional professional services” means—

(a) displaying such health promotion leaflets as the Board may, in consultation with the Local Pharmaceutical Committee, approve; and

(b) publishing a leaflet (“practice leaflet”) which shall include—

(i) a list of the pharmaceutical services which the chemist has undertaken to provide and for which his name is included in the pharmaceutical list;

(ii) the name, address and telephone number of the premises from which he provides those services and the hours in each day of the week during which he provides those services from those premises;

(iii) the arrangements made by the chemist to provide, or such arrangements as the chemist has made with any other chemist to provide, pharmaceutical services to any person who needs those services in an emergency or outside of the normal hours during which the chemist provides pharmaceutical services; and

(iv) the procedure by which any person may comment upon the provision of pharmaceutical services provided by the chemist; and

(c) keeping records in connection with drugs supplied to any person—

(i) who claims exemption under regulation 7(1)(c) of the Charges for Drugs and Appliances Regulations (Northern Ireland) 1997(17) (which provides that those aged 60 or over are exempt from prescription charges); or

(ii) who, in the opinion of the chemist providing the drug, is likely to have difficulty understanding the nature and dosage of the drug provided and the times at which it is to be taken,

in circumstances where the nature of the drug is such that, in the opinion of the chemist providing it, the same or a similar drug is likely to be prescribed for that person regularly on future occasions.

(3) In paragraph (2)(c) “records” includes a record of—

(a) the name and address of the person to whom the drug is supplied;

(b) the name, quantity and dosage of the drug supplied; and

(c) the date on which the drug is supplied.

Supply of drugs for terminally ill patients

5.  Where—

(a) the Department is satisfied that an institution is wholly or mainly concerned with the care of terminally ill patients; and

(b) that institution has made a special arrangement with the Department,

a chemist may supply drugs for patients of that institution on presentation by that institution of a composite order form signed by a doctor.

Pharmaceutical list

6.—(1) Each Board shall prepare a list to be called “the pharmaceutical list” of the names of persons, other than doctors and dentists, who undertake to provide pharmaceutical services and of the addresses of the premises within the Board's area from which these persons undertake to provide such services. A list prepared under this regulation shall also—

(a) state the nature of the pharmaceutical services to be provided;

(b) state the days and hours during which the premises are open; and

(c) show chemists as a separate category of persons within that list.

(2) A person (hereinafter referred to in this regulation as an “applicant”)—

(a) who wishes to be included in the pharmaceutical list for the provision of pharmaceutical services; or

(b) whose name is already included in the pharmaceutical list, but who intends—

(i) to open within the Board's area, additional premises from which to provide pharmaceutical services; or

(ii) to relocate within the Board's area, the premises from which he provides pharmaceutical services; or

(iii) to provide pharmaceutical services other than those already listed in relation to him from premises which are already included in the pharmaceutical list,

shall apply to the Board in accordance with whichever version of Form A set out in Part I (chemists) or in Part II (persons other than chemists) of Schedule 3 is appropriate or in the case of an application under paragraph (4), whichever version of Form A (MR) set out in Part I or Part II of that Schedule is appropriate.

(3) Where an application is made and—

(a) the applicant intends to provide the same pharmaceutical services from premises from which, at the time of the application, another person whose name is included in the pharmaceutical list provides those services, in place of that person; and

(b) the condition specified in paragraph (5) is fulfilled,

the Board shall grant the application.

(4) Where an application is made and—

(a) the applicant intends to relocate to new premises, within the neighbourhood in which he provides pharmaceutical services, from the premises already listed in relation to him, and to provide from those new premises the same pharmaceutical services which he is listed as providing from his existing premises; and

(b) the Board is fully satisfied that the relocation is a minor relocation; and

(c) the condition specified in paragraph (5) is fulfilled,

the Board shall grant the application and shall notify its decision in accordance with paragraph 3(1) of Schedule 4.

(5) The condition referred to in paragraphs (3)(b) and (4)(c) is that in either case the provision of those particular pharmaceutical services will not be interrupted, except for such period as the Board may allow.

(6) In this regulation the reference to a minor relocation is to one where there will be no significant change in the neighbourhood population in respect of which pharmaceutical services are provided by the applicant and other circumstances are such that there will be no appreciable effect on the pharmaceutical services provided by the applicant or any other person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the neighbourhood of the premises named in the application.

(7) Before satisfying itself that a relocation is a minor relocation the Board shall seek and take into account the views of the Local Pharmaceutical Committee.

(8) In the case of an application to which paragraph (4) applies, where the Board is not fully satisfied that the relocation is a minor relocation, it shall not grant the application but shall give notice in writing of its decision in accordance with paragraph 3(1) of Schedule 4.

(9) An application made in any case other than one to which paragraph (3) or (4) applies shall be granted by the Board, after the procedures set out in Schedule 4 have been followed, only if it is satisfied that the provision of pharmaceutical services at the premises named in the application is necessary or desirable in order to secure adequate provision of pharmaceutical services in the neighbourhood in which the premises are located by persons whose names are included in the pharmaceutical list.

(10) Where an application is granted by the Board, it shall be in accordance with whichever version of Form C, set out in Part I (chemists) or Part II (persons other than chemists) of Schedule 3 is appropriate.

(11) Where an application is granted in accordance with paragraph (9), the Board may grant it in respect of some or all of the pharmaceutical services specified in that application.

(12) An application, other than one to which paragraph (4)(a) applies, which is made by a person who is qualified to have his name registered under the Pharmacy (Northern Ireland) Order 1976(18) by virtue of Article 8(2)(c) of that Order (Qualification by European diploma) shall not be granted unless the applicant satisfies the Board that he has the knowledge of English which, in the interests of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the Board's area.

(13) Where an application is granted, the Board shall make the relevant entries in the pharmaceutical list only after the expiry of the period within which an appeal against the decision to grant the application might be intimated or the conclusion of all the appeal procedures, whichever is appropriate.

Removal from pharmaceutical list

7.—(1) Where a chemist has—

(a) died; or

(b) is no longer a chemist,

the Board shall remove his name from the pharmaceutical list.

(2) Where a Board determines that a chemist, whose name has been included for the preceding 6 months in the pharmaceutical list, has not during that period provided pharmaceutical services, it may, subject to paragraph (5)(b), remove that chemist's name from that list.

(3) A period during which the chemist was suspended by direction of the Tribunal does not count towards the period of 6 months referred to in paragraph (2).

(4) Before making any determination under paragraph (2) the Board shall—

(a) give the chemist 28 days' notice of its intention;

(b) afford the chemist an opportunity of making representations to the Board in writing or, if he so desires, in person; and

(c) consult the Local Pharmaceutical Committee.

(5) Nothing in this regulation shall—

(a) prejudice the right of a chemist to be included again in the pharmaceutical list; or

(b) apply to a chemist who is performing a period of relevant service, and paragraph (2) shall not apply in respect of any such chemist until 6 months after he has completed that relevant service.

Scheme for securing proper pharmaceutical services

8.  The Board, after consultation with the Local Pharmaceutical Committee, shall prepare a scheme for testing the quality and amount of the drugs and appliances supplied and the accuracy of dispensing.

Standards of, and payments for, drugs and appliances

9.—(1) For the purpose of enabling arrangements to be made for the provision of pharmaceutical services, the Department shall compile and publish a statement (in these Regulations referred to as "the Drug Tariff') which it may amend from time to time and which, subject to paragraph (2), shall include—

(a) the list of appliances;

(b) the list of chemical reagents;

(c) the list of drugs for the time being approved by the Department for the purposes of Article 63 of the Order;

(d) the prices on the basis of which the payment for drugs and appliances ordinarily supplied is to be calculated;

(e) the method of calculating the payment for drugs not mentioned in the Drug Tariff;

(f) the method of calculating the payment for containers and medicine measures;

(g) the dispensing or other fees payable in respect of the supply of drugs and appliances and of the provision of supplemental services and of additional professional services;

(h) arrangements for claiming fees, allowances and other remuneration for the provision of pharmaceutical services; and

(i) the method by which a claim may be made for compensation for financial loss in respect of oxygen equipment.

(2) The Drug Tariff may state in respect of any specified fee falling within paragraph (1)(g), or any other specified fee, allowance or other remuneration in respect of the provision of pharmaceutical services by chemists, that the determining authority for that fee, allowance or other remuneration for those chemists is the Board, and in such a case paragraphs (4) and (5) shall apply.

(3) The prices referred to in paragraph (1)(d) may be fixed prices or may be subject to monthly or other periodical variations to be determined by reference to fluctuations in the cost of drugs and appliances.

(4) The Board shall consult the Local Pharmaceutical Committee before making any determination by virtue of paragraph (2).

(5) A determination made by the Board by virtue of paragraph (2) shall include the arrangements for claiming the specified fees, allowances or other remuneration, and shall be published by the Board in such manner as it thinks suitable for bringing the determination to the attention of the chemists in its area.

Payments to suspended chemists

10.—(1) The Board shall make payments to any chemist who is suspended by direction of the Tribunal in accordance with a determination made by the Department in relation to such payments.

(2) The Department shall make a determination in accordance with paragraph (1) after consultation with such organisation which is, in the opinion of the Department, representative of the general body of chemists, and that determination shall be published with the Drug Tariff.

(3) The determination may be amended from time to time by the Department, after consultation with the organisation referred to in paragraph (2), and any amendments shall also be published with the Drug Tariff.

(4) A determination made by the Department by virtue of paragraph (1)—

(a) shall be such as to secure that, as far as reasonably practicable, and after making adjustments for any reduction in expenses, the suspended chemist receives payments at a rate corresponding to his remuneration under the Drug Tariff (but excluding any payments made by virtue of regulation 9(1)(1) and (i)) during the 12 months ending with the direction for suspension by the Tribunal;

(b) may include provision that payments in accordance with the determination are not to exceed a specified amount in any specified period;

(c) in a case to which paragraph 8B(3) of Schedule 11 to the Order(19) applies, shall provide for the payments to be reduced to take account of any payments which the suspended chemist receives for providing pharmaceutical services other than as a principal.

PART III PROVISION OF PHARMACEUTICAL SERVICES BY DOCTORS

Provision of pharmaceutical services for immediate treatment or personal administration

11.  A doctor—

(a) shall provide to a patient any appliance or drug, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before a provision can otherwise be obtained; and

(b) may provide to a patient any appliance or drug, not being a Scheduled drug, which he personally administers or applies to that patient.

Arrangements for provision of pharmaceutical services by doctors

12.—(1) Where the Board is satisfied that a person, by reason of distance, inadequacy of means of communication or other exceptional circumstances, would have serious difficulty in obtaining any necessary drugs not being Scheduled drugs or appliances from a chemist it may, unless the person notifies it that, notwithstanding, he desires to obtain such drugs or appliances from a chemist, require the doctor in whose list of patients the person is included to supply to that person until further notice such drugs or appliances as would otherwise under these Regulations have been supplied by a chemist.

(2) Where the number of such persons, in respect of whom a doctor has been required to supply necessary drugs and appliances under paragraph (1), exceeds 80 per cent of the total number of persons on his list of patients the Board may require the doctor to supply any necessary drugs and appliances to all persons on his list of patients.

(3) Paragraph (2) shall not apply in respect of any person who notifies the Board that, notwithstanding, he desires to obtain any necessary drugs or appliances from a chemist.

(4) A doctor shall be entitled to receive reasonable notice from the Board that he is required to undertake the supply of drugs or appliances, or that a requirement to undertake such supply is to be discontinued.

(5) The Board may make arrangements with doctors on the obstetric list for the supply of drugs and appliances to patients for whom they have undertaken to provide maternity medical services.

PART IV PHARMACEUTICAL COMMITTEE

Constitution

13.  The Pharmaceutical Committee shall be constituted by the Agency in accordance with Schedule 5 for the purpose of carrying out duties in connection with—

(a) the testing of drugs and appliances;

(b) the accuracy of dispensing; and

(c) payments to chemists.

PART V MISCELLANEOUS

Publication of particulars

14.—(1) The Board shall make available for inspection at its offices up to date copies of the following documents—

(a) the pharmaceutical list;

(b) these Regulations;

(c) the Drug Tariff; and

(d) any determination made by the Board by virtue of regulation 9 or by the Department by virtue of regulation 10(1).

(2) The Board may—

(a) make copies of documents referred to in paragraph (1) available for inspection at such other places in its area as appear to it convenient for informing all persons interested; or

(b) publish at such places a notice of the places and times at which such copies may be seen.

(3) The Board shall send a copy of the pharmaceutical list to the Department, the Agency, each Local Pharmaceutical Committee, each Local Medical Committee and each local Dental Committee, and shall, within 14 days of any alteration in the pharmaceutical list, so inform each of them in writing.

Exercise of choice of chemist in certain cases

15.  An application to a chemist for the provision of pharmaceutical services may be made (other than by the chemist concerned)—

(a) on behalf of any child by either parent, or in the absence of both parents, the other person who has parental responsibility for or care of the child; or

(b) on behalf of any person by another person authorised by the first mentioned person.

Claims and overpayments

16.—(1) Any claim for fees, allowances or other remuneration by chemists or doctors shall be made in accordance with the provisions of the Drug Tariff or, as the case may be, in accordance with any arrangements for claiming them included in a determination made by the Board by virtue of regulation 9 or by the Department by virtue of regulation 10(1).

(2) Where it considers that a payment has been made to a chemist, or to a doctor who provides pharmaceutical services, in circumstances when it was not due, the Board, except to the extent that the Department, on the application of the Board, directs otherwise, shall draw the overpayment to the attention of the chemist or the doctor, and—

(a) where the overpayment is admitted by him; or

(b) where the overpayment is not so admitted but, the matter having been referred under regulation 5(1) of the Disciplinary Procedures Regulations for investigation, the Board, or the Department on appeal, decides that there has been an overpayment,

the amount overpaid shall be recoverable by the Board by deduction from the remuneration of the doctor or chemist or otherwise.

(3) Recovery of an overpayment under this regulation shall be without prejudice to the investigation of an alleged breach of the terms of service of that chemist or doctor.

Transitional provisions

17.  Where, before the commencement of these Regulations, an appeal has been made under—

(a) regulation 38(4) of the Health and Personal Social Services (General Medical and Pharmaceutical Services) Regulations (Northern Ireland) 1973(20); or

(b) paragraph 4 of Schedule 4B to those Regulations, by a Board;

the provisions of those Regulations shall continue to apply as respects that appeal as if these Regulations had not been made.

Sealed with the Official Seal of the Department of Health and Social Services on 15th August 1997.

(L.S.)

Joan Dixon

Assistant Secretary

Sealed with the Official Seal of the Department of Finance and Personnel on 15th August 1997.

(L.S.)

D. Thomson

Assistant Secretary

SCHEDULE 1 PROVISIONS CONFERRING POWERS EXERCISED IN MAKING THESE REGULATIONS

Column 1	Column 2
Provision	Relevant Amendments
The Health and Personal Social Services (Northern Ireland) Order 1972(21)
Article 55(3)	None
Article 63(1), (2) and (2A) to (2D)	The Health and Personal Social Services (Northern Ireland) Order 1978(22), Article 14;
	The Health and Personal Social Services (Amendment) (Northern Ireland) Order 1986(23), Article 5(1);
	The Pharmaceutical Qualifications (EEC Recognition) Regulations (Northern Ireland) 1987(24), regulation 4;
	The Health and Personal Social Services (Northern Ireland) Order 1991, Article 31(1); and
	The Pharmaceutical Services (Northern Ireland) Order 1992(25)
Article 64(1) and (2)	The Health and Personal Social Services (Amendment) (Northern Ireland) Order 1986, Article 5(2); and
	The Health and Personal Social Services (Northern Ireland) Order 1991, Article 31 (2).
Article 95	None
Article 106(b)	None
Article 107(6)	None
Schedule 1, paragraph 8	The Health and Personal Social Services and Public Health (Northern Ireland) Order 1986(26), Article 19 and Schedule
Schedule 3, paragraph 7	None
The Health and Medicines (Northern Ireland) Order 1988(27)
Article 10	None
The Medicines Act 1968(28)
Section 103(3)	The Health and Medicines Act 1988(29), Section 22(4)

Regulations 2(1) and 3(2)

SCHEDULE 2

PART I GENERAL

Incorporation of provisions

1.  Any provisions of the following affecting the rights and obligations of chemists or doctors who provide pharmaceutical services shall be deemed to form part of the terms of service for chemists or, as the case may be, of the terms of service for doctors who provide pharmaceutical services—

(a) these Regulations;

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of Article 63 of the Order; and

(c) so much of the Disciplinary Procedures Regulations as relates to—

(i) the investigation of questions arising between chemists and persons receiving pharmaceutical services and other investigations to be made by a pharmaceutical discipline committee or a joint discipline committee and the action which may be taken by a Board as a result of such investigations; and

(ii) appeals to the Department from decisions of a Board.

PART II TERMS OF SERVICE FOR CHEMISTS

Provision of pharmaceutical services

2.—(1) Where any person presents on a prescription form—

(a) an order for drugs, not being Scheduled drugs, or appliances, signed by a doctor; or

(b) an order for drug specified in Schedule 11 to the Medical Regulations, signed by, and endorsed on its face with the reference "S. 11 ", by a doctor in accordance with paragraph 49(2) of Schedule 2 to those Regulations;

(c) an order for listed drugs or medicines, signed by a dentist or his deputy or assistant; or

(d) an order for listed drugs or medicines, or listed appliances, signed by a nurse prescriber,

a chemist shall, with reasonable promptness, supply the drugs or medicines so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

(2) If the person presenting the prescription form asks the chemist to do so—

(a) he shall give an estimate of the time when the drugs, medicines or appliances will be ready; and

(b) if they are not ready by then, he shall give a revised estimate of the time when they will be ready and so on.

(3) A chemist shall not accept for dispensing any prescription form received at premises other than a pharmacy.

(4) A chemist shall not supply any drugs or appliances ordered on a prescription form other than at a pharmacy.

(5) Any drug which is provided as part of pharmaceutical services and included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, shall comply with the standard or formula specified therein.

(6) Subject to sub-paragraphs (7) to (19) a chemist shall provide pharmaceutical services only in response to and in accordance with an order on a prescription form, signed as specified in sub-paragraph (1).

(7) Where an order, not being an order to which the Poisons Regulations (Northern Ireland) 1983(30) or the Misuse of Drugs Regulations (Northern Ireland) 1986(31) apply, which is issued by a doctor, a dentist or a nurse prescriber on a prescription form for drugs does not prescribe their quantity, strength or dosage, a chemist may supply the drugs in such strength and dosage as in the exercise of his professional skill, knowledge and care he considers to be appropriate and, subject to sub-paragraph (8), in such quantity as he considers to be appropriate for a course of treatment, for the patient to whom the order relates, for a period not exceeding 5 days.

(8) Where an order to which sub-paragraph (7) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more drugs; or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for supply as part of pharmaceutical services except in such packages that the minimum available package contains a quantity appropriate to a course of treatment for a patient for a period of more than 5 days, the chemist may supply that minimum available package.

(9) Where any drug, not being one to which the Misuse of Drugs Regulations (Northern Ireland) 1986 apply, ordered by a doctor, dentist or nurse prescriber on a prescription form, is available for supply by a chemist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile;

(b) effervescent or hygroscopic;

(c) a liquid preparation for addition to bath water;

(d) a coal tar preparation;

(e) a viscous preparation; or

(f) packed at the time of its manufacture in a calendar pack or special container,

the chemist shall, subject to sub-paragraph (8), supply the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(10) A chemist shall not supply, pursuant to sub-paragraph (9), a drug in a calendar pack where, in his opinion, it was the intention of the doctor, dentist or nurse prescriber who ordered the drug that it should be provided only in the exact quantity ordered.

(11) In this paragraph—

(a) “calendar pack” means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and

(b) “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(12) Where, in a case of urgency, a doctor or nurse prescriber personally known to a chemist requests him to supply a drug, the chemist may supply that drug before receiving a prescription form, provided that—

(a) that drug is not a Scheduled drug;

(b) that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971(32), other than a drug which is specified in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 1986; and

(c) the doctor or nurse prescriber undertakes to give the chemist such a prescription form within 72 hours.

(13) Except as provided in sub-paragraph (14), a chemist shall not supply a Scheduled drug, by way of pharmaceutical services or otherwise, in response to an order by name, formula or other description on a prescription form.

(14) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form either by that name or by its formula, a chemist may supply a drug which has the same specification notwithstanding that it is a Scheduled drug, provided that where a Scheduled drug is a pack which consists of a drug in more than one strength, such supply does not involve the supply of part only of the pack.

(15) Where a drug which is ordered as specified in sub-paragraph (14) combines more than one drug, that sub-paragraph shall apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(16) A chemist shall supply any drug which he is required to supply under this paragraph in a suitable container.

(17) Subject to sub-paragraph (18), a chemist may, at the request of a doctor licensed under the provision of the Misuse of Drugs (Notification of and Supply to Addicts) Regulations (Northern Ireland) 1973(33), arrange to supply, in accordance with a special prescription form provided for the purpose by the Agency and signed by the licensed doctor, such drugs or appliances as may be so ordered. If the prescription form includes directions that part of the total supply of drugs ordered thereon shall be supplied on a stated day or days the chemist shall comply with such directions.

(18) A chemist shall not be in breach of his terms of service if—

(a) he refuses to enter into an arrangement to supply drugs or appliances under sub-paragraph (17); or

(b) having entered into such an arrangement he gives the licensed doctor seven days notice in writing of his intention to terminate it.

(19) A chemist shall not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of his presenting an order for drugs or appliances on a prescription form.

Professional standards

3.—(1) A pharmacist whose name is on the pharmaceutical list shall provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

(2) A chemist who employs a pharmacist in connection with the provision of pharmaceutical services shall secure that the pharmacist complies with the requirements set out in sub-paragraph (1).

Premises and hours

4.—(1) Pharmaceutical services shall be provided at each of the premises from which the chemist has undertaken to provide pharmaceutical services at such times as, following an application in writing by the chemist to the Board, shall have been approved in his case by it or, on appeal, the Department, in accordance with the following provisions of this paragraph.

(2) The Board shall not approve any application made by a chemist in relation to the times at which he is to provide pharmaceutical services unless it is satisfied that—

(a) the times proposed are such that a pharmacist will normally be available—

(i) subject to sub-paragraph (4), for no less than 30 hours in any week; and

(ii) on 5 days in any such week; and

(b) the hours when a pharmacist will normally be available in any week are to be allocated between the days on which he will normally be available in that week in such a manner as is likely to meet the needs of persons in the neighbourhood for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (1.00 p.m. on an early closing day).

(3) In this paragraph—

(a) “available” means, in relation to a pharmacist, available to provide pharmaceutical services of the kind he has undertaken to provide;

(b) “an early closing day” means any week day when most shops in the neighbourhood are habitually closed after the hour of 1.00 p.m.

(4) The Board may approve an application to provide pharmaceutical services for less than 30 hours in any week provided that it is satisfied that the provision of pharmaceutical services in the neighbourhood is likely to be adequate to meet the need for such services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day) at times when the pharmacist is not available.

(5) Subject to sub-paragraph (6), in determining any application, the Board shall either—

(a) grant approval;

(b) grant approval subject to any requirements that it considers appropriate for the purpose of ensuring that a chemist is available for the provision of pharmaceutical services at such times as are necessary to meet the need for such services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day); or

(c) refuse approval.

(6) Where the Board is considering whether to grant approval subject to any requirements, as mentioned in sub-paragraph (5)(b), it shall consult the Local Pharmaceutical Committee before determining the application.

(7) A Board shall notify the chemist in writing of its determination, and, where it refuses an application or grants an application subject to any requirements under sub-paragraph (5)(b), it shall send to the chemist a statement in writing of the reasons for its determination or, as the case may be, for the imposition of the requirements and of the chemist's right of appeal under sub-paragraph (8).

(8) A chemist may, within 30 days of receiving a notification pursuant to sub-paragraph (7), appeal in writing to the Department against any refusal of approval or against any requirement imposed pursuant to sub-paragraph (5)(b).

(9) The Department may, when determining an appeal, either confirm the determination of the Board or substitute its own determination for that of the Board.

(10) The Department shall notify the chemist in writing of its determination and shall in every case include with the notification a written statement of the reasons for the determination.

(11) At each of the premises at which a chemist provides pharmaceutical services he shall exhibit—

(a) a notice specifying the times at which the premises are open for the provision of drugs and appliances; and

(b) at times when the premises are not open, a notice, where practicable legible from outside the premises, specifying the addresses of other chemists in the neighbourhood included in the pharmaceutical list and the times at which pharmaceutical services may be obtained from those addresses.

(12) Where a chemist is prevented by illness or other reasonable cause from complying with his obligations under this paragraph, he shall, where practicable, make arrangements with one or more chemists whose premises are situated in the neighbourhood for the provision of pharmaceutical services during that time.

(13) A chemist may apply to a Board for a variation of the times at which, in accordance with a determination under this paragraph (“the earlier determination”), a pharmacist is required to be normally available, and sub-paragraphs (1) to (10) shall apply to the making and determination (“the subsequent determination”) of an application under this sub-paragraph as if it were the first application by that chemist for the purposes of this paragraph.

(14) Where an application made under sub-paragraph (13) is approved, the earlier determination mentioned in that sub-paragraph shall cease to have effect and the subsequent determination mentioned in that sub-paragraph shall have effect instead—

(a) where the subsequent determination is made by a Board and no appeal is made, from the day falling 8 weeks after the date on which the chemist receives notification of that Board's determination; or

(b) where the subsequent determination is made on appeal, from the day falling 8 weeks after the date on which the chemist receives notification of the Department's determination.

(15) Where it appears to the Board, after consultation with or at the request of the Local Pharmaceutical Committee, that the times at which a pharmacist is available no longer meet the needs of persons in the neighbourhood for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day), it may review the terms of—

(a) any approval granted by the Board under sub-paragraph (5)(a) or (b) or by the Department under sub-paragraph (9); or

(b) any direction given under sub-paragraph (l 7)(a) by the Board or, on appeal, by the Department.

(16) On any review under sub-paragraph (15) the Board shall—

(a) give notice to the chemist of its proposed changes in the times at which the pharmacist is to be available; and

(b) allow the chemist 30 days within which to make representations to the Board about its proposals.

(17) After considering any representations made in accordance with sub-paragraph (16)(b), the Board shall either—

(a) direct the chemist to revise the times at which the pharmacist is to be available in the manner specified in the direction; or

(b) confirm that the existing times at which the pharmacist is to be available continue to meet the need for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day).

(18) The Board shall notify the chemist in writing of its determination under sub-paragraph (17), and where it gives a direction under head (a) of that sub-paragraph it shall include with the notification a statement in writing of the reasons for its determination and of the chemist's right of appeal under sub-paragraph (19).

(19) A chemist may, within 30 days of receiving notification under sub-paragraph (18), appeal in writing to the Department against a direction under sub-paragraph (17)(a).

(20) Sub-paragraphs (9) and (10) shall apply to any appeal made under sub-paragraph (19) but as though in sub-paragraph (10) any reference to a determination were a reference to a decision.

(21) A chemist in respect of whom a direction is given under sub-paragraph (17)(a) shall revise the times of availability of the pharmacist so as to give effect to the direction—

(a) where the direction is given by the Board and no appeal is made, not later than 8 weeks after the date on which he receives notification under sub-paragraph (18); or

(b) where the direction is given or confirmed on appeal, not later than 8 weeks after the date on which he receives notification of the Department's decision.

(22) Where it appears to the Board, after consultation with the Local Pharmaceutical Committee, that the times at which a pharmacist is available—

(a) on any working day before the hour of 9.30 a.m. or after the hour of 5.30 p.m. (or 1.00 p.m. on an early closing day); or

(b) on any Sunday or public holiday,

are not adequate to meet the needs of persons in the neighbourhood for pharmaceutical services at those times or on those days, the Board may (subject to sub-paragraphs (23) to (25)) direct the chemist to revise the times at which the pharmacist is to be available in the manner specified in the direction.

(23) The Board shall not give a direction under sub-paragraph (22) unless a fee, allowance or other remuneration to be paid to the chemist to whom the direction is to be given is included in the Drug Tariff or has been determined by the Board by virtue of regulation 9(2) (as the case may be).

(24) Before giving any direction under sub-paragraph (22) the Board shall—

(a) give notice to the chemist of the revised times at which it proposes the pharmacist to be available; and

(b) allow the chemist 30 days within which to make representations to the Board about its proposals,

and shall take any such representations into account.

(25) The Board shall notify the chemist in writing of a direction under sub-paragraph (22), and shall include with the notification a statement in writing of the reasons for its direction and of the chemist's right of appeal under sub-paragraph (26).

(26) A chemist may, within 30 days of receiving notification under sub-paragraph (25), appeal in writing to the Department against a direction under sub-paragraph (22).

(27) Sub-paragraphs (9) and (10) shall apply to any appeal made under sub-paragraph (26) but as though any reference to a determination—

(a) in sub-paragraph (9) were to a direction; and

(b) in sub-paragraph (10) were to a decision.

(28) A chemist in respect of whom a direction is given under sub-paragraph (22) shall revise the times at which the pharmacist is to be available so as to give effect to the direction—

(a) where the direction is given by the Board and no appeal is made, not later than 8 weeks after the date on which he receives notification under sub-paragraph (25); or

(b) where the direction is given or confirmed on appeal, not later than 8 weeks after the date on which he receives notification of the Department's decision.

Supply of drugs and fitting of appliances

5.—(1) Drugs shall be supplied either by or under the direct supervision of a pharmacist.

(2) Where the pharmacist referred to in sub-paragraph (1) is employed by a chemist, the pharmacist shall not be one—

(a) who, having been disqualified under paragraph 3(b) of Schedule 11 to the Order(34) (or any corresponding provision in force in England and Wales or Scotland) from inclusion in the pharmaceutical list (or, in England and Wales, the pharmaceutical list of a Health Authority or, in Scotland, the pharmaceutical list of a Health Board), is also the subject of a declaration under paragraph 3(c) of Schedule 11 to the Order (or any corresponding provision in force in England and Wales or Scotland) that he is not fit to be engaged in any capacity in the provision of pharmaceutical services; or

(b) who is suspended by direction of the Tribunal, other than in a case falling within paragraph 8B{3) of Schedule 11 to the Order.

(3) Subject to paragraph 2(1), a chemist shall make all necessary arrangements—

(a) for measuring a person who presents on a prescription an order for an appliance of a type requiring measurement and fitting by the chemist; and

(b) for fitting the appliance.

Particulars of pharmacists

6.  A chemist shall give to the Board, if it so requires, the name of any pharmacist employed by him for the supply of drugs for persons from whom he has accepted an order under paragraph 2.

Charges for drugs

7.—(1) Subject to regulations made under Article 98 of, and Schedule 15 to, the Order(35), all drugs, containers and appliances supplied under these terms of service shall be supplied free of charge.

(2) Where a chemist supplies a container in response to an order for drugs signed by a doctor under paragraph 48 of Schedule 2 to the Medical Regulations or by a nurse prescriber or supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the chemist, the container and equipment shall remain the property of the chemist.

Inspection of records and premises

8.  A chemist who has undertaken to provide additional professional services shall, on receipt of a request from the Board, make available to the Board all records kept in accordance with regulation 4(2)(c) and shall permit the Board or another person on its behalf at any reasonable time to inspect the premises from which those services are provided for the purpose of satisfying itself that those services are being provided in accordance with the undertaking.

Remuneration of chemists

9.—(1) The Board shall make payments, calculated in the manner provided by the Drug Tariff or in accordance with any determination made by virtue of regulation 9(2) (subject to any deduction required to be made by regulations made under Article 98 of, and Schedule 15 to, the Order) to chemists in respect of drugs and appliances, containers, medicine measures and dispensing or other fees.

(2) The Board shall make such payments, if any, as are provided for by the Drug Tariff or in accordance with any determination made by virtue of regulation 9(2) to chemists who provide additional professional services.

(3) Where a chemist so requests, the Board shall afford him reasonable facilities for examining all or any of the forms on which the drugs or appliances supplied by him were ordered, together with particulars of the amounts calculated to be payable in respect of such drugs and appliances and the Board shall take into consideration any objections made by the chemist in relation to those amounts.

(4) Where so requested by the Local Pharmaceutical Committee or any organisation which is, in the opinion of the Department, representative of the general body of chemists, the Board shall give the Local Pharmaceutical Committee or the organisation in question similar facilities for examining such forms and particulars mentioned in sub-paragraph (3) relating to all or any of the chemists which it represents.

(5) If the Department, after consultation with any organisation mentioned in sub-paragraph (4) and with the Pharmaceutical Committee constituted in accordance with regulation 13 and Schedule 5, is satisfied at any time that the method of payment provided for in this paragraph is such that undue delay in payment may be caused thereby, it may direct that the amounts to be payable to a chemist shall be calculated by such other method, whether by averaging the amounts payable to a chemist or otherwise, as may appear to the Department to be designed to secure that—

(a) payment may be made within a reasonable time; and

(b) that payments to a chemist shall, as nearly as may be, remain the same as if the payments had been calculated in accordance with the first mentioned method of payment, and payments calculated by any such other method shall be deemed for all purposes to be payments made in accordance with these Regulations.

Withdrawal from pharmaceutical list

10.—(1) Subject to sub-paragraph (2), a chemist may at any time give notice in writing to the Board that he wishes to withdraw his name from the pharmaceutical list and his name shall be removed accordingly on the expiry of the period of—

(a) 3 months from the date of such notice; or

(b) such shorter period as the Board may agree.

(2) Where representations are made to the Tribunal under Schedule 11 to the Order (disqualification of persons providing certain services) that the continued inclusion of a chemist in the pharmaceutical list would be prejudicial to the efficiency of pharmaceutical services, he shall not, except with the consent of the Department, be entitled to have his name removed from such a list pending the determination of the proceedings on those representations.

Complaints

11.—(1) Subject to sub-paragraph (2), a chemist shall establish and operate in accordance with this paragraph, a procedure (in this paragraph and in paragraph 12 referred to as a “ complaints procedure”) to deal with any complaints made by or on behalf of any person to whom he has provided pharmaceutical services.

(2) The complaints procedure to be established by a chemist may be such that it also deals with complaints made in relation to one or more other chemists.

(3) The complaints procedure to be established by a chemist who provides pharmaceutical services from more than one set of premises may be such that it relates to all those premises together.

(4) A complaints procedure shall apply to complaints made in relation to any matter reasonably connected with the chemist's provision of pharmaceutical services and within the responsibility or control of—

(a) the chemist;

(b) where the chemist is a corporate body, any of its directors or former directors;

(c) a partner or former partner of the chemist;

(d) any pharmacist employed by the chemist;

(e) any employee of the chemist other than one falling within head (d);

and in this paragraph and paragraph 12, references to complaints are references to complaints falling within this sub-paragraph.

(5) A complaint may be made on behalf of any person with his consent, or—

(a) where he is a child—

(i) by either parent, or in the absence of both parents, the person having parental responsibility for or care of him; or

(ii) where he is in the care of a Board or HSS trust to whose care he has been committed under the provisions of the Children (Northern Ireland) Order 1995(36) by a person duly authorised by that Board or trust; or

(iii) where he is in the care of a voluntary organisation, by that organisation or a person duly authorised by it; or

(iv) where he is in a training school, by the manager of that training school; or

(b) where he is incapable of making a complaint, by a relative or other adult person who has an interest in his welfare.

(6) A complaint may be made as respects a person who has died by a relative or other adult person who had an interest in his welfare, or when he was a child falling within head (a)(ii), (iii) or (iv) of sub-paragraph (5), by the Board or HSS trust, or voluntary organisation, or the manager of the training school as the case may be.

(7) A complaints procedure shall comply with the following requirements—

(a) the chemist shall specify a person (who need not be connected with the chemist and whom in the case of an individual, may be specified by his job title) to be responsible for receiving and investigating all complaints;

(b) all complaints shall be—

(i) recorded in writing;

(ii) acknowledged, either orally or in writing, within the period of 3 working days beginning with and including the day on which the complaint was received by the person specified under head (a) or, where that is not possible, as soon as reasonably practicable; and

(iii) properly investigated;

(c) within the period of 10 working days beginning with and including the day on which the complaint was received by the person specified under head (a) or, where that is not possible, as soon as reasonably practicable, the complainant shall be given a written summary of the investigation and its conclusions;

(d) where the investigation of the complaint requires consideration of any records relating to the person as respects whom the complaint is made, the person specified under head (a) shall inform him or the person acting on his behalf if the investigation will involve disclosure of information contained in those records to a person other than a person falling within sub-paragraph (4)(a) to (e); and

(e) the chemist shall keep a record of all complaints and copies of all correspondence relating to complaints, but such records shall be kept separate from any records relating to the person by whom the complaint was made.

(8) At each of the premises at which the chemist provides pharmaceutical services he shall provide information about the complaints procedure, and give the name (or job title) and address of the person specified under sub-paragraph (7)(a); and where he provides supplemental services he shall provide the same information to any person to whom he has given advice in accordance with regulation 3(3)(a).

12.—(1) A chemist shall co-operate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with directions given under Article 17(1) of the Order, whether the investigation follows one under the complaints procedure or not.

(2) The co-operation required by sub-paragraph (1) includes—

(a) answering questions reasonably put to the chemist by the Board;

(b) providing any information relating to the complaint reasonably required by the Board; and

(c) attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and of which due notice has been given), if the chemist's presence at the meeting is reasonably required by the Board.

PART III TERMS OF SERVICE FOR DOCTORS WHO PROVIDE PHARMACEUTICAL SERVICES

13.  Subject to paragraph 14, where a doctor is required by a Board under regulation 12 to supply drugs or appliances to a patient—

(a) he shall record an order for the supply of any drugs, or appliances which are needed for the treatment of a patient on a prescription form completed in accordance with paragraph 48(2) of the doctors' terms of service;

(b) he shall supply those drugs or appliances in a suitable container; and

(c) he shall supply to the patient a drug specified in Schedule 11 to the Medical Regulations only where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied.

14.—(1) Paragraph 13 does not apply to drugs, medicines or appliances ordered on a prescription form signed by a nurse prescriber.

(2) Where a patient presents an order on a prescription form for listed drugs, or appliances, signed by a nurse prescriber, to a doctor who is required by regulation 12 to supply drugs or appliances to that patient, the doctor may supply to the patient such of the drugs or appliances so ordered as he supplies in the normal course of his practice.

(3) Listed drugs or appliances supplied under this paragraph shall be supplied in a suitable container.

15.—(1) Subject to sub-paragraph (2), a doctor who is required by a Board under regulation 12 to supply drugs or appliances to a patient shall not supply to a patient any Scheduled drug, except that, where he has ordered a drug which has an appropriate non-proprietary name either by the name or by its formula, he may supply a drug which has the same specification notwithstanding that it is a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non-proprietary name).

(2) Nothing in this paragraph shall prevent a doctor supplying, otherwise than under these terms of service, a Scheduled drug for a patient.

16.—(1) The provisions of paragraphs 43 to 47 of Schedule 2 to the Medical Regulations (Fees) apply in respect of the supply of any drugs or appliances by a doctor as they apply in respect of prescriptions for drugs and appliances.

(2) Where paragraph 44(2) of Schedule 2 to the Medical Regulations applies and the doctor has supplied any drug or appliance for which, in the case of a person on his list of patients, he would have been entitled to payment from the Agency, the Agency shall credit him with the appropriate amount.

17.  A doctor who is required by a Board under regulation 12 to supply drugs or appliances to a patient or who otherwise provides pharmaceutical services shall secure that the practice based complaints procedure he has established and operates in accordance with paragraphs 52 and 53 of Schedule 2 to the Medical Regulations applies in relation to any matter reasonably connected with his provision of pharmaceutical services as they apply as respects his provision of general medical services.

Regulation 6(2) and 6(10)

SCHEDULE 3

PART I

Regulation 6(2)

FORM A

Regulation 6(2)

FORM A(MR)

Regulation 6(2)

FORM B

Regulation 6(10)

FORM C

PART II

Regulation 6(2)

FORM A

Regulation 6(2)

FORM A (MR)

Regulation 6(2)

FORM B

Regulation 6(10)

FORM C

Regulation 6(4), (8) and (9)

SCHEDULE 4

PART I PROCEDURE ON APPLICATIONS

Notification of applications

1.—(1) Where, on receipt of any properly completed application under regulation 6(2), the Board is satisfied that the application is one to which regulation 6(9) applies, it shall, within 5 working days, give written notice of the application to—

(a) the Local Pharmaceutical Committee;

(b) the Local Medical Committee;

(c) any person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the Board's area and whose interests may, in the opinion of the Board, be significantly affected if the application were granted;

(d) any Board whose boundary is within one mile of the proposed premises;

and any person so notified may, within 30 days from the date on which the notification was sent to him, make written representations to the Board.

(2) Any Board which is notified under sub-paragraph (1)(d) shall, within 5 working days, give written notice of the application to—

(a) its Local Pharmaceutical Committee;

(b) its Local Medical Committee;

(c) any person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the Board's area and whose interests may, in its opinion, be significantly affected if the application were granted;

any any person so notified may, within 30 days from the date on which the notification was sent to that Board, make written representations to the Board to whom the application was made.

(3) Any notice given under sub-paragraph (1) or (2) shall include a statement of the right to make representations in accordance with that sub-paragraph.

Determination of applications

2.—(1) In considering an application to which regulation 6(9) applies, the Board shall have regard to—

(a) the pharmaceutical services already provided in the neighbourhood of the premises named in the application, by persons whose names are included in the pharmaceutical list;

(b) any representations received by the Board under paragraph 1; and

(c) any information available to the Board which, in its opinion, is relevant to the consideration of the application.

(2) The Board may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations.

(3) In any case in which the Board decides to hear oral representations, it shall give the applicant and any person from whom it received representations under paragraph 1 reasonable notice of the meeting at which such representations are to be heard.

(4) The applicant and any person mentioned in sub-paragraph (3) shall be permitted to be assisted in making representations at any such meeting by some other person, but a person shall not be entitled to be heard in the capacity of counsel or solicitor.

(5) The procedure by which representations are heard shall be such as the Board may determine.

(6) The functions of the Board under this paragraph shall be exercised by the Pharmacy Practices Committee on behalf of the Board.

Notification of decisions

3.—(1) In the case of an application to which regulation 6(4) applies, the Board shall, within 14 days, give to the applicant and the persons mentioned in paragraph 1 notice of its decision on the application, together with its reasons therefor and any right of appeal under paragraph 4.

(2) In the case of an application to which regulation 6(9) applies, the Board shall, within 14 days of having been notified in accordance with paragraph 11(5), give to the applicant and any person who has made representations to the Board in accordance with paragraph 1(1) or (2), notice of its decision on the application, together with the reasons therefor and any right of appeal under paragraph 4.

Appeals

4.—(1) Where the Board has determined an application to which regulation 6(4) applies, the applicant or any person mentioned in paragraph 1(1)(c) or 1(2)(c) may appeal against the decision of the Board on the application, and notice of any such appeal shall be received by the Board within 21 days from the date on which notification of the Board's decision was sent to him.

(2) Where the Board has determined an application to which regulation 6(9) applies, the applicant or any person who was given notice of the application under paragraph 1(1)(c) or 1(2)(c) and who has made representations to the Board in accordance with paragraph 1 (1) or 1 (2) may appeal against the decision of the Board on the application, and notice of any such appeal shall be received by the Board within 21 days from the date on which notification of the Board's decision was sent to him.

(3) Any notice of appeal under this paragraph shall contain a concise statement of the facts and contentions upon which the appellant intends to rely.

(4) The Board shall refer a notice of appeal under this paragraph to the chairman of the National Appeal Panel appointed in accordance with Part IV.

(5) If the chairman of the National Appeal Panel, after considering the notice of appeal, is of the opinion that the notice discloses no reasonable grounds of appeal or that the appeal is otherwise vexatious or frivolous, he may determine the appeal by dismissing it forthwith, in which case he shall notify the Board accordingly.

(6) In any other case the National Appeal Panel shall be convened in accordance with Part IV and shall thereafter determine the appeal.

PART II PHARMACY PRACTICES COMMITTEE

Establishment

5.  The Board shall appoint a committee (“ the Pharmacy Practices Committee”) and the provisions of Part III shall apply to the proceedings of that committee.

Functions

6.  The Pharmacy Practices Committee shall, on behalf of the Board, exercise the function of the Board under regulation 6(9) in accordance with paragraph 2(6).

Membership

7.—(1) The Pharmacy Practices Committee shall consist of 7 members of whom—

(a) 2 shall be the chairman and vice-chairman respectively and be appointed as such by the Board; the chairman shall be a member of the Board, appointed, under paragraph 3(1)(a) or (b) of Schedule 1 to the Order, and neither shall be a doctor, dentist, ophthalmic optician, pharmacist, or a person or the employee of a person whose name is included in the pharmaceutical list;

(b) 3 shall be pharmacists of whom—

(i) one shall be a pharmacist whose name is not included in the pharmaceutical list and who is not the employee of a person whose name is included in that list; and he shall be appointed by the Board from persons nominated by the Pharmaceutical Society of Northern Ireland; and

(ii) 2 shall be pharmacists each of whom is included in the pharmaceutical list or is an employee of a person whose name is included in that list; and each shall be appointed by the Board from persons nominated by such organisation which is, in the opinion of the Board, representative of the general body of chemists; and

(c) 2 shall be appointed by the Board but neither shall be a pharmacist or a person, or employee of a person, whose name is included in the pharmaceutical list, or be a doctor who is required to supply drugs or appliances in terms of regulation 12; and not more than one of the 2 members so appointed shall be a doctor, dentist or ophthalmic optician.

(2) Persons to act as deputies for, and corresponding in number to, each of those categories of person appointed pursuant to sub-paragraph (1)(b)(i), (b)(ii) and (c) shall, provided they satisfy the criteria specified in the relevant sub-paragraph, be appointed by the Board, and in the absence of any of those persons a deputy from the appropriate category shall be entitled to act in his place.

(3) If a nomination sought for the purposes of sub-paragraph (1)(b)(i) or (ii) is not made before such date as the Board may determine, the Board may appoint as a member a person who satisfies the criteria specified in the relevant sub-paragraph.

8.  The Board shall prepare and maintain lists of the persons who have been appointed, in accordance with paragraph 7(1)(a) or (b)(i) or (b)(ii) or (c) as the case may be, and who currently serve as members of the Pharmacy Practices Committee, and shall provide the Department with a copy of such lists.

PART III PROCEDURE AT MEETINGS OF THE PHARMACY PRACTICES COMMITTEE

Declaration of interest

9.—(1) Before any meeting of the Pharmacy Practices Committee begins the chairman, or vice-chairman if acting as chairman, shall ask the members intending to be present whether, in respect of any matter to be considered at the meeting any of them—

(a) has an interest to declare; or

(b) is associated with a person who has such interest,

and any such member who has or, as the case may be, is associated with a person who has any such interest shall declare it accordingly.

(2) Any member who has, pursuant to the provisions of sub-paragraph (1), declared an interest or who, in the opinion expressed to the meeting, of the chairman or vice-chairman if acting as chairman as the case may be, should have declared such an interest, shall not be present at the consideration or discussion of that matter or the voting on it, and a deputy who has no such interest may act in his place.

Quorum

10.  No business shall be transacted at a meeting of the Pharmacy Practices Committee unless the chairman or vice-chairman acting as chairman, one member appointed under each of paragraph 7(1)(b)(i) and (ii) and 2 other members appointed under paragraph 7(1)(a) or (c) are present.

Voting and notification of decision

11.—(1) Subject to sub-paragraphs (2), (3) and (4), every application considered by the Pharmacy Practices Committee shall be considered by all members present, but be determined only by a majority of votes of the members present who are entitled to vote.

(2) Any member appointed by virtue of paragraph 7(1)(b)(i) or 7(1)(c) and the vice-chairman, provided he is not acting as chairman, are entitled to vote.

(3) A member appointed by virtue of paragraph 7(1)(b)(ii) is not entitled to vote and shall withdraw immediately before a decision on an application by voting takes place.

(4) The chairman, or vice-chairman if acting as chairman, shall not be entitled to vote at any meeting except in the case of an equality of votes of the other persons present and voting, in which case he shall have a casting vote.

(5) The Pharmacy Practices Committee shall within 5 working days of making its decision give written notification of it to the Board together with reasons therefor.

Standing Orders

12.  Subject to the provisions of these Regulations, the Board may make, vary or revoke standing orders with respect to the terms of office of members of the Pharmacy Practices Committee, the procedure of that committee and the making of reports of its proceedings to the Board.

Effect of vacancy or defect in appointment

13.  The proceedings of the Pharmacy Practices Committee shall not be invalidated by any vacancy in its membership, or any defect in a member's appointment.

PART IV NATIONAL APPEAL PANEL

Nominees for the National Appeal Panel

14.—(1) The Board shall submit the names of its nominees for the National Appeal Panel to the Department and shall advise of any changes in such nominees.

(2) The Department shall request the Pharmaceutical Society of Northern Ireland and such organisation which is, in the opinion of the Department, representative of the general body of chemists, to submit to the Department their nominees for the National Appeal Panel.

Chairman and Vice-Chairman of National Appeal Panel

15.—(1) After consultation with all Boards, the Pharmaceutical Society of Northern Ireland and such organisation which is, in the opinion of the Department, representative of the general body of chemists, the Department shall appoint persons as chairman and vice-chairman of the National Appeal Panel.

(2) The persons appointed in accordance with sub-paragraph (1) shall not be a doctor, dentist, ophthalmic optician, pharmacist, or a person or employee of a person whose name is included in the pharmaceutical list.

Membership

16.—(1) In any case in which paragraph 4(6) applies, the Department shall arrange to convene in accordance with this paragraph the National Appeal Panel, the members of which shall be drawn from—

(a) the lists maintained in accordance with paragraph 8; and

(b) the nominees mentioned in paragraph 14.

(2) A member of the National Appeal Panel shall not be a member of—

(a) the Board or the Pharmacy Practices Committee which considered the application; or

(b) any Board which was notified in accordance with paragraph 1(1)(d) and which submitted representations in accordance with that paragraph.

(3) The National Appeal Panel shall consist of 9 members of whom—

(a) one shall be chairman appointed in accordance with paragraph 15;

(b) one shall be vice-chairman and likewise be appointed as such in accordance with paragraph 15;

(c) 4 shall be pharmacists one of whom has been nominated by the Pharmaceutical Society of Northern Ireland and the other 3 by such organisation which is, in the opinion of the Department, representative of the general body of chemists; and of those 4 members only 2 shall be persons whose names are, or who are employees of persons whose names are, included in the pharmaceutical list; and

(d) 3 shall have been nominated by a Board, but none shall be a pharmacist or a person, or employee of a person, whose name is included in the pharmaceutical list, or be a doctor who is required to supply drugs and appliances under regulation 12; and not more than one of those 3 shall be a doctor, dentist or ophthalmic optician.

Declaration of interest

17.—(1) Before the start of any meeting of the National Appeal Panel the chairman, or vice-chairman if acting as chairman, shall ask the members intending to be present whether, in respect of the appeal to be considered at the meeting, any of them—

(a) has an interest to declare; or

(b) is associated with a person who has such interest,

and any such member who has or, as the case may be, is associated with a person who has, any such interest shall declare it accordingly.

(2) Any member who has, pursuant to sub-paragraph (1), declared an interest or who, in the opinion, expressed to the meeting, of the chairman or vice-chairman as the case may be, should have declared such an interest, shall not be present at the consideration or discussion of that appeal or the voting on it.

Quorum

18.  No business of the National Appeal Panel shall be transacted unless the chairman, or vice-chairman if acting as chairman, and 2 members who are appointed under paragraph 16(3)(c) and are entitled to vote, and 2 members appointed under paragraph 16(3)(d) are present.

Voting

19.—(1) Subject to sub-paragraphs (2), (3) and (4), every appeal considered by the National Appeal Panel shall be considered by all members present, but be determined only by a majority of votes of the members present who are entitled to vote.

(2) A member appointed in accordance with paragraph 16(3)(c) and whose name is not included in the pharmaceutical list and who is not an employee of a person whose name is included in that list, and the vice-chairman, provided he is not acting as chairman, are entitled to vote.

(3) A member—

(a) who is appointed in accordance with paragraph 16(3)(c) and whose name is included in the pharmaceutical list, or who is an employee of a person whose name is included in that list; or

(b) who is appointed by virtue of paragraph 16(3)(d),

is not entitled to vote and shall withdraw immediately before a decision on an appeal by voting takes place.

(4) The chairman, or vice-chairman if acting as chairman, shall not be entitled to vote at any meeting except in the case of an equality of votes of the other persons present and voting, in which case he shall have a casting vote.

Decisions by the National Appeal Panel

20.—(1) The National Appeal Panel shall determine an appeal in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the appeal without hearing any oral representations, and its decision in respect of that appeal shall be final.

(2) The National Appeal Panel shall, within 5 working days of making its decision, give written notification of that decision together with reasons therefor to the Board to whom the application was made.

(3) The Board shall, within 14 days of receipt of such notification, notify the applicant and all persons mentioned in paragraph 1 of that decision together with the reasons therefor.

Regulation 13 and Schedule 2 paragraph 9(5)

SCHEDULE 5 PHARMACEUTICAL COMMITTEE

1.  The Pharmaceutical Committee constituted by the Agency after consultation with the Boards and such organisation which is, in the opinion of the Agency, representative of the general body of chemists and such other persons as it considers appropriate, shall consist of a chairman and such number of other members as the Agency thinks fit.

2.  The chairman shall be a pharmacist appointed by the Department.

3.  The term of office of members shall be determined by the Agency.

4.  Where the place of a member becomes vacant before the expiration of his term of office whether by death, resignation or otherwise, the vacancy shall be filled by the Agency after consultation in accordance with paragraph 1 and if necessary with the Pharmaceutical Committee and any other person so appointed shall hold office for the remainder of the term of office of the member who died, resigned or otherwise vacated his office as the case may be.

5.  A member of the Pharmaceutical Committee may resign his membership by giving to the Agency notice in writing.

6.  Where any member of the Pharmaceutical Committee—

(a) is absent from the meetings of the Committee for more than 6 months consecutively (except for a reason approved by the Agency);

(b) has become bankrupt or has made a composition with his creditors; or

(c) is convicted of an indictable offence;

the Agency shall forthwith by resolution, declare the office to be vacant and shall notify that fact in such manner as it thinks fit and thereupon the office shall become vacant.

7.  A member of the Pharmaceutical Committee may vote upon any matter which touches the interests of members of his profession (himself included) but shall not vote upon any matters touching only his individual professional interests.

8.  The proceedings of the Pharmaceutical Committee shall not be invalidated by any vacancy in the membership of the Committee or by any defect in the appointment of its members.

9.  A member of the Pharmaceutical Committee who is a member of a Board shall cease to be a member of that Committee if he ceases to be a member of that Board.

EXPLANATORY NOTE

(This note is not part of the Regulations.)

These Regulations consolidate, with amendments, those provisions of the Health and Personal Social Services (General Medical and Pharmaceutical Services) Regulations (Northern Ireland) 1973 (“the 1973 Regulations”) which relate to pharmaceutical services. The provisions of the 1973 Regulations which relate to General Medical Services are consolidated with amendments, in the Health and Personal Social Services (General Medical Services) Regulations (Northern Ireland) 1997. These Regulations now regulate the terms on which pharmaceutical services are provided under the Health and Personal Social Services (Northern Ireland) Order 1972.

The Regulations make the following principal changes—

(1) A chemist whose name is to be removed from the pharmaceutical list because pharmaceutical services have not been provided now has a right of appeal.

(2) A right of appeal has been provided against the Board's determination of an application for a minor relocation of premises.

(3) The terms of service now require a chemist to obtain the approval of the Board for the times at which he proposes to provide pharmaceutical services from the premises in respect of which he is included on the pharmaceutical list. Provision is made for the Board to grant approval subject to any conditions that it considers necessary to meet local needs. A chemist may apply for a variation of the approved times or of any condition and may appeal either against a refusal to approve his proposed times or against the imposition of any conditions.

(4) The regulations contain terms of service for doctors who provide pharmaceutical services (Part III of Schedule 2).

(1)

S.I. 1972 (N.I. 14)

(2)

Article 63 is amended by Article 14 of S.I. 1978/1907 (N.I. 26); Article 5(1) of S.I. 1986/2023 (N.I. 20); regulation 4 of S.R. 1987 No. 457; Article 31 of S.I. 1991/194 (N.I. 1) and Article 3 of S.I. 1992/2671 (N.I. 18)

(3)

1968 c. 67

(4)

S.R. 1996 No. 137

(5)

Article 55 is amended by Article 5 of S.I. 1991/194 (N.l. 1)

(6)

S.R. 1997 No. 380

(7)

1968 c. 67; section 103(5) is amended by section 22(6) of the Health and Medicines Act 1988 (c. 49)

(8)

14 & 15 Geo. 6 c. 65

(9)

S.I. 1979/291

(10)

1980 c. 9

(11)

Paragraphs 8A and 8B were inserted by Article 4 of S.I. 1995/2704 (N.l. 24)

(12)

1979 c. 36; the Parts of the professional register are determined by S.I. 1983/667, amended by S.I. 1989/104 and 1989/1455

(13)

Approved by S.l. 1983/873, to which there are amendments not relevant to these Regulations

(14)

S.I. 1991/194 (N.I. 1)

(15)

1954 c. 33 (N.l.)

(16)

S.I. 1992/3204 (N.I. 20)

(17)

S.R. 1997 No. 382

(18)

S.I. 1976/1213 (N.I. 22) as amended by S.R. 1987 No. 457

(19)

Paragraph 8B(3) of Schedule 11 is inserted by Article 4 of S.I. 1995/2704 (N.I. 24)

(20)

S.R. & O. 1973 No. 421 as amended by S.R. 1987 No. 247

(21)

S.I. 1972/1265 (N.I. 14)

(22)

S.I. 1978/1907 (N.I. 26)

(23)

S.I. 1986/2023 (N.I. 20)

(24)

S.R. 1987 No. 457

(25)

S.I. 1992/2671 (N.I. 18)

(26)

S.I. 1986/2229 (N.I. 24)

(27)

S.I. 1988/2249 (N.I. 24)

(28)

1968 c. 67

(29)

1988 c. 49

(30)

S.R. 1983 No. 201; relevant amending Regulations are S.R. 1985 No. 345, S.R. 1987 No. 240 and S.R. 1994 No. 217

(31)

S.R. 1986 No. 52; relevant amending Regulations are S.R. 1987 No. 68, S.R. 1988 No. 206, S.R. 1989 No. 346, S.R. 1991 No. 1, S.R. 1995 No. 305, S.R. 1995 No. 480 and S.R. 1996 No. 353

(32)

1971 c. 38

(33)

S.R. & O. (N.I.) 1973 No. 1 80 as amended by S.R. 1984 No. 17

(34)

Schedule 11 is amended by Article 3 of, paragraph 2 of Schedule 1 to, Article 17 of and Part I of Schedule 6 to S.I. 1984/1158 (N.I. 8) and Articles 3 to 6 of S.I. 1995/2704 (N.I. 14)

(35)

Article 98 is amended by Article 34 of, and Part II of Schedule 5 to, S.l. 1991/194 (N.l. 1)

(36)

S.I. 1995/755 (N.I. 2)